Tume Lyvonne N, Blackwood Bronagh, McAuley Daniel F, Morris Kevin, Peters Mark J, Jordan Joanne, Walsh Timothy Simon, McIlmurray Lisa
School of Health and Society, University of Salford, Manchester, UK.
Paedaitric Intensive Care Unit, Alder Hey Children's NHS FT, Liverpool, UK.
Nurs Crit Care. 2023 May;28(3):396-403. doi: 10.1111/nicc.12810. Epub 2022 Jun 22.
Published reports of complex interventions in randomized controlled trials often lack sufficient detail to allow trial replication and adoption into practice.
The aim of this paper is to describe our experience of using the Template for Intervention Description and Replication (TIDieR) checklist in reporting a recent trial of sedation and ventilation weaning in critically ill children (the Sedation and Weaning in Children [SANDWICH] trial).
The TIDieR 12-point checklist has been used to detail and describe the specific SANDWICH trial intervention and methods of implementation.
RESULTS/DISCUSSION: Overall, we found the checklist a useful tool to direct and ensure consistency of reporting of our complex intervention used in a multi-centre clinical trial. We experienced some minor limitations in classifying training materials and delivery mode into one item because of the overlapping nature of this component.
Using the TIDieR checklist to report complex interventions tested in trials provides a structured, systematic way of describing necessary detail. This allows clinicians to understand the theory behind the intervention, how it should be delivered, and the resources required.
The SANDWICH intervention had a significant beneficial effect on reducing time on ventilation for children. The detailed description of the team-based intervention will aid replication, implementation and monitoring of fidelity in other paediatric intensive care units.
随机对照试验中已发表的复杂干预措施报告往往缺乏足够细节,无法让试验得以复制并应用于实践。
本文旨在描述我们在报告近期一项针对危重症儿童镇静和撤机的试验(儿童镇静与撤机[SANDWICH]试验)时使用干预描述与复制模板(TIDieR)清单的经验。
采用TIDieR 12项清单来详细说明和描述SANDWICH试验的具体干预措施及实施方法。
结果/讨论:总体而言,我们发现该清单是指导和确保多中心临床试验中复杂干预措施报告一致性的有用工具。由于该部分内容存在重叠性质,我们在将培训材料和交付方式归为一项时遇到了一些小限制。
使用TIDieR清单报告试验中测试的复杂干预措施,提供了一种结构化、系统化的方式来描述必要细节。这使临床医生能够理解干预背后的理论、应如何实施以及所需资源。
SANDWICH干预措施对缩短儿童通气时间有显著有益效果。基于团队的干预措施的详细描述将有助于其他儿科重症监护病房进行复制、实施和保真度监测。